The present invention relates to a conventional I.V. infusion set or blood collection assembly. Such an assembly includes an elongated small gauge plastic flexible tubing material having at one end thereof a needle and a body for holding the needle. Usually, the needle body is adhered to the one end of the flexible tube by friction. At any rate, the needle body includes wings extending on either side for the phlebotomist or user to grasp and hold the needle body for inserting the needle into a patient. Such assemblies may be used for infusing medication into a patient or for collecting blood from a patient. Generally, at the end of the flexible tube opposite the needle body is a female luer connection for connecting supplies of fluid to be infused or for connecting some sort of apparatus for collecting blood, as required.
As everyone knows who has any connection with the medical field in the last several years, there is great concern that users of such devices as described above may be contaminated with the blood of a patient by accidental sticks of the contaminated needle. For this reason, many developments have taken place for providing some sort of covering for the contaminated needle, once it is removed from the patient. These structures usually involve some sort of shield arrangement which moves in place over the contaminated needle, once it has been removed from the patient. Representative of such arrangements include, for example, the device shown and described in U.S. Pat. No. 4,170,993 which is a fairly early structure utilizing a rather involved locking slot arrangement for moving the contaminated needle into a covered position.
Two fairly simple structures for retracting a contaminated needle into a sleeve protection arrangement include, for example, U.S. Pat. Nos. 4,676,783 and 4,781,692 both of which utilize a friction engagement structure for holding the covering shield over the contaminated needle. However, it has been found that neither one of these structures provide a positive locking arrangement for insuring that the needle does not become uncovered. That is, the frictional engagement is not positive enough in many instances to prevent accidental slippage of the needle out of the shield under certain circumstances in a hospital environment, for example.
A fairly recent structure for covering contaminated needles includes the device shown and described in U.S. Pat. No. 4,943,283. This structure does not accommodate the usual handling wings normally utilized for blood collection, but rather a finger control structure which may not be satisfactory for some phlebotomists who wish to have the conventional wing structure for control. Other fairly recent arrangements for covering the contaminated needle in an infusion and/or blood collection assembly of the kind discussed herein, include U.S. Pat. Nos. 4,888,001 and 4,834,708. The former has a wing structure with cooperating grooves on the wings and cooperating locking abutments on the wings which allow for the wings to be folded to cover and lock over a contaminated needle. This structure is desirable in the sense that it provides a positive covering of the needle against the needle being uncovered by some unpredictable movement. However, the structure is very expensive to make for the kind of environment where many thousands of such needles are used daily. Moreover, the arrangement is somewhat unwieldy to handle during the covering procedure for covering the contaminated needle. Finally, the '708 patent mentioned above provides positive covering of the needle but includes a very involved and expensive structure for manufacture in the environment which this invention is directed.
U.S. Pat. No. 4,941,881 issued Jul. 17, 1990 includes a tube mounted I.V. infusion set with a protective sheath similar to that taught and claimed in the present application. The structure includes foldable wings which are utilized by the phlebotomist to grasp and maneuver the needle for insertion into a patient for use of the needle. When withdrawing the needle from the patient, the wings must be folded and held in place for movement in the folded position through a slot back to a locking position. While this arrangement provides positive locking of the needle inside an enclosed shield once the wings are moved to the locking position, it does require positive camming of the wings in a folded position for the rearward movement of the contaminated needle together with the associated wings from the use position to the locked position. Such maneuvering may be ponderous in the environment of removing a needle from the skin of a patient and attempting to handle the needle and the patient simultaneously.
With this invention, by contrast, an I.V. infustion and/or blood collection assembly is provided with a very inexpensive two-part semi-flexible shield assembly. The arrangement is such that the two parts may be joined together at one end with a flexible hinge, and connected at the opposite end with a fixed locking arrangement, so that the shield is closed over the needle body of a blood collection set. The arrangement is such that the cooperating parts of the shield form a forward non-locking use position for the wings and a rearward fixed locking position for moving the needle into a protected permanently locked position. The two locking positions are joined by flexible slots which allow the movement of the wings, without any flexing thereof or handling, from the use position to the locked position. Thus, the assembly provides simple rearward movement of the needle body and wings, which is the automatic movement of the contaminated needle into a shielded positively locked position for subsequent disposal.
Other objects and advantages of this invention will be apparent from the following description, the accompanying drawings and the appended claims.